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Regulatory Landscape for Raw Materials: CMC Considerations

ISPE

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Published 2002.

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EMA Executive Director Speaks on the Value of Adaptation, Trust, & Collaboration

ISPE

Cooke, who has over 30 years of experience in international regulatory affairs, with 18 years in leadership roles, took the helm at EMA as director in November 2020, early in the pandemic, after having worked at EMA since 2002, serving as head of inspections initially and then as head of international affairs from 2009 to 2016.

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Paving the way for anti-Abeta active immunotherapy

European Pharmaceutical Review

Active anti-Abeta immunotherapies In the 2000s, the concept of active immunotherapy targeting Abeta in Alzheimer’s patients was assessed with the ELAN vaccine (AN1792), consisting of full-length aggregated Abeta 1-42 peptide mixed with the QS21 adjuvant. 8 However, as this trial was not placebo-controlled, conclusions are difficult to draw.

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A history of Johnson & Johnson

pharmaphorum

The company has also faced claims that it did not adequately communicate the risks of its opioid painkillers in its marketing, contributing to the US’ ‘opioid epidemic’, and that its talc products could contain small amounts of asbestos and lead to cancer. Weldon became the Chairman and CEO of J&J in 2002.

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